Delivering fluids to and extracting fluids from the human body is a basic part of the physicians task in the treatment of patients. Fluids delivered include a variety of solutions, and fluids removed include human blood. FIG. twelve illustrates typical components of a fluid delivery or extraction system; some of these components include an intravenous solution bag (I.V. bag) or bottle container, a syringe, medication bottle, nasogastric tube, a urethral catheter, tubing, etc. To interact with and utilize these components the physician is often exposed to unprotected needles. Furthermore, the interconnections among devices often disconnect, spilling contaminated fluids upon patients, health care personnel, and hospital equipment. A great deal of time is consumed in making often unreliable connections among fluid transport systems. The couplings presented in the present invention overcome the difficulties of the prior art and permit the construction of a unified system, e.g., a system where all components are joined with the same universal couplers.
Quick connect assemblies have been known in the prior art for many years. Areas in which quick-connect couplings have been applied include hydraulics, pneumatics, plumbing, and so on. Such connector assemblies, while widely used in areas such as industrial tubing connectors and electrical connectors, have had limited successful application to areas involving fluid delivery for medical or health care purposes. Few of the prior art quick-connect, fluid flow couplings have successfully incorporated needle or needle-like structures within the internal structure of the coupling in such a way that keeps the fluid flow apart from the mechanical coupling, while also giving full protection to the user against accidental pricking by the needle or other needle-like structure.
In the delivery of fluids in medical systems in common use today, e.g., in intravenous anti-biotic delivery systems, needles are common components of the fluid delivery apparatus, and the accidental disconnection of a needle forming the fluid connection is unfortunately all too common. Such accidental disconnections present safety hazards to staff personnel and threat of infections to the patient, particularly in a time of the emergence of diseases such as AIDS which carry fatal consequences with a slip of the wrong needle. An ever growing larger quantity of used needles must now be disposed of, again generating health hazards to hospital staff personnel and others involved in waste handling.
At present, the most commonly used connector appears to be the Luer lock which requires a turning or screwing motion in the application for mechanical locking and involves tapered internal surfaces for liquid sealing. The Luer Lock design is not the only connector design used in the medical area requiring rotational or screw actions for locking. The various connector designs in U.S. Pat. No. 4,668,217 to Isono, for example, all require a rotational action for connection.
More recently there has appeared in the patent literature a series of devices containing protected diaphragm or septum piercing, needle-like structures having quick-connect locks or quick-connect locks in combination with rotational locks. In U.S. Pat. No. 4,759,756 to Fonnan et. al., a "reconstitution device" is presented containing a protected needle structure and using a rotational split-jaw locking device in combination with a multiple-jaw or finger snap-gripping device. In U.S. Pat. No. 4,950,260 to Bonaldo for a "medical connector" a device is presented containing a protected needle structure using a locking cap, which is flipped into position for locking, in combination with a luer lock. In U.S. Pat. No. 4,927,423 to Malmborg, protected needle-like piercing members are used in combination with snap-lock circular beads within circular chambers for joining other chambers filled with liquids. In U.S. Pat. No. 4,998,927 to Vaillancourt a protected needle-like structure is used to pierce a septum using a flexible structure and is joined to external elements via luer lock structures.
In U.S. Pat. No. 5,037,405 to Crosby a protected needle is enclosed after connection within a hinged compartment which is then locked using a clasp mechanism. For U.S. Pat. No. 4,998,925 a protected needle is enclosed within a sleeve which is joined via frictional fits at both ends to other fluid system members. In U.S. Pat. No. 4,998,713 to Vaillancourt a protected needle is used within a Y connector using a cam-action lock mechanism. In U.S. Pat. No. 4,981,469 to Whitehouse et al. a protected needle structure is contained within an assembly joined via luer locks.
A number of locking mechanisms are available which are now being adapted for enclosed needle protection. In U.S. Pat. No. 4,969,879 an "alligator clip" mechanism, long familiar to those working in the electronics area, is used to join a stepped, tapered nozzle to a receptacle for said stepped, tapered nozzle. this alligator clip mechanism is now being used to join a protected needle structure for fluid connections. Some companies using the alligator clip concept include Block Medical, Inc. and Baxter Healthcare Corporation in such devices as "protective needle locks". Recently the Baxter Corporation has introduced an alligator clip device called a "Needle Less Cannula." This device is small but has the drawbacks of requiring significant squeezing force to open the alligator clips to make the fluid flow connection and a tendency for the device to slip from the hand. None has been fully satisfactory in meeting the needs in this field.
For example, one problem is the delay incurred during diagnosis and/or therapy because of the reoccurring need for an exact fitting. In an emergency situation, all to frequently only the wrong sizes for connecting pieces or pieces having non-complimentary systems to execute the connection, are found. For example, a friction fitting Toomey syringe may be needed to inject solution into a patient, and only a Luer locking syringe is available. Lack of a standardized or universal connector, particularly in the medical field where off times under emergency situations, a variety of different components must be connected/disconnected bother quickly and securely.
Another problem experienced with known types of connectors is the lack of separation between the fluid flow from the mechanical connection. Fluids coming in contact with the connection itself, over time, will cause difficulty in operation of the connection. For example, one problem experienced in medical emergency rooms is that the fluids, e.g., blood, cause difficulty in quickly disengaging two connector components. This could be particularly crucial in procedures such as a heart operation involving use of a cardiac catheter, where the operation of its Luer lock has been adversely affected by the fluid flow itself, by either being unable to smoothly separate, producing additive problems in trying to get a grip on delicate tubing, for example, or the opposite problem, in having the connector fall apart, an enhanced possibility with the use of friction fittings.
The following only briefly illustrates some of the disastrous consequences that originate from such a faulty medical connector: unexpected loss of blood could occur from a patient. A loss of medication or food being fed into a patient could be interrupted, with the fluids spewing onto the bed or floor. Unanticipated interruption of a medical fluid could cause contamination of the patient and/or the health care worker. When a connector is used for the flow of a gaseous fluid, such as oxygen, the friction connectors now most prevalent always present the possibility of separation, resulting in no oxygen or inadequate oxygen to the patient. When critical body measurements are taking place, such as by means of a bladder catheter tube, inadvertent connector separation results in inaccurate measurement of body fluids and an open source for urinary track infections. When the connector is used with a surgical drainage table, for example, should the connector fall apart, immediate contamination is possible again of both the patient and the health care personnel.
Medical connectors, while useful in certain situations, have not been able to overcome these disadvantages, and thus their usefulness has thus been limited.
The connector quick-connect, quick-disconnect mechanical locking system described herein can, of course, be applied to medical devices other than the connectors. A catheter insertion device can be made utilizing the mechanical principles described herein. Such device consists of a two-spring loaded cylinder whereupon an initial squeeze, the first spring is released driving the catheter into the patient. Upon a second squeeze the central stiletto or trochar contained within the catheter is removed and a female port ready to receive the male connector of the present invention is established.